Here is a recipe on how to push through the MDR process in the shortest possible time. Based on my recent panel presentation at the MedFIT 2024, I have put together some key tips and ideas on what to consider as a beginner, start-up or any organization newly starting on this road.  The record time we managed to complete a project was 9 months!

‍

1. Plan carefully, and once your plan is ready, stick to it. Just like building a house, you need a budget, a timeline, and a list of available resources.

2. Plan, but don’t over-plan or be too rigid with it. Over-engineering your foundation in an attempt to prepare for everything will only lead to extra costs and delays.  

3. Gather a core team that you trust and make sure your development team is accompanied by a QA/RA expert from the very beginning, not at the end of your project. Like building a house, you need to bring in the right professionals at the right stage to make everything fit together.

4. Trust your QA/RA specialists, in-house or external, and make sure they know your team and staff well. It’s like hiring a trusted plumber to fix the piping in your house, not an unfamiliar electrician.

‍

The right amount of advance planning convinces investors, and don’t forget that you can also book with the notified body ahead of time. The investors will see well-organized planning and will support it accordingly.

‍

Based on our experience, following the MDR from the start with an understanding how to interpret the regulations saves development time and improves patient safety because that is why the MDR regulations have been established in the first place.  

‍

Also, remember that no one builds alone – choose your partner. Start by deciding whether you want to work on your own or collaborate with others and consider carefully where you might need support.  

‍

Today, there are an increasing number of countries outside Europe who are beginning to understand the EU regulations and comply. And this is excellent! In my opinion, we in Europe have achieved something we can truly be proud of.  Of course there are challenges, but I believe that here we can set an example on how to do things correctly!

‍

if you'd like to hear more about how to plan for your project while accounting for MDR, contact me or fill the form below to suggest a meeting slot that suits you.